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0.8% Affirmagen - Taiwan Registration a55dc1033a8cca120586d5e0cec1a0ef

Access comprehensive regulatory information for 0.8% Affirmagen in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number a55dc1033a8cca120586d5e0cec1a0ef and manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC.. The authorized representative in Taiwan is DKSH TAIWAN LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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a55dc1033a8cca120586d5e0cec1a0ef
Registration Details
Taiwan FDA Registration: a55dc1033a8cca120586d5e0cec1a0ef
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Device Details

0.8% Affirmagen
TW: 0.8%่‰พ่Šฌ็‘ช้‡‘็ด…่ก€็ƒ่ฉฆๅŠ‘(ๆททๅˆ็ดฐ่ƒž)
Risk Class 3
MD

Registration Details

a55dc1033a8cca120586d5e0cec1a0ef

Ministry of Health Medical Device Import No. 030083

DHA05603008301

Company Information

United States

Product Details

A qualitative test to confirm the ABO blood group antibodies (A1 and B) in the blood. It needs to be used with the BioVue System.

B Hematology and pathology devices

B9175 Automated Blood Sorting and Antibody Testing System

Imported from abroad

Dates and Status

Oct 26, 2017

Oct 26, 2027